Thyroid DysfunctionNCT06739330
Thyroid Dysfunction and Its Association With Metabolic Dysfunction-Associated Fatty Liver Disease
An observational study of Thyroid Dysfunction and Metabolic Dysfunction-Associated Fatty Liver Disease, run by Tanta University at 1 site in Egypt.
Trial summary
This study aims to evaluate the prevalence of thyroid dysfunction and its association with metabolic dysfunction-associated fatty liver disease. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Thyroid Dysfunction, Metabolic Dysfunction-Associated Fatty Liver Disease
- What is being tested?
- Fibroscan
- Type of treatment
- Medical device
- How many people
- 150 participants
- Where
- 1 siteEgypt
- Study dates
- 19 Dec 2024to 1 May 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: This cross-sectional case-control study will be carried out on 150 patients with metabolic dysfunction-associated fatty liver disease (MAFLD) at Tanta University Hospitals for a period from October 2024 to April 2025 after approval from the Institutional Ethical Committee.
Who may be able to join
- Age ≥ 18 years.
- Both sexes.
- Patients with metabolic dysfunction-associated fatty liver disease (MAFLD).
Who cannot join
- History of thyroid disease or treatment (e.g., thyroid nodules, thyroid cancer, hypothyroidism, and hyperthyroidism).
- Patients with alcoholic liver disease take more than 40g of alcohol (or four units) per day.
- Viral hepatitis.
- Pregnant women.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Tanta University
Tanta, El-Gharbia, 31527
Shimaa A Meshaal, MD, 00966559806580, shaimaa.meshaal2013@med.tanta.edu.eg
About this study
This study aims to evaluate the prevalence of thyroid dysfunction and its association with metabolic dysfunction-associated fatty liver disease.
Read the detailed description
One of the most common causes of chronic liver diseases worldwide is metabolic dysfunction-associated fatty liver disease (MAFLD), which affects about 30% of adults. Thyroid hormones are critical in maintaining metabolic homeostasis throughout life and are intimately linked to the liver.
Dysfunctions of the thyroid gland have been implicated as one of the most important risk factors of MAFLD due to its important role in the hepatic synthesis of fatty acid and cholesterol. Maintaining liver metabolism requires thyroid function to be normal, while thyroid disorders may lead to liver disease progression.
- Being tested
- Fibroscan
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FibroscanDevice
Fibroscan will be used to assess the stages of fibrosis and steatosis using Dimensional ultrasound TE (transient elastography). Dimensional ultrasound TE (transient elastography) will be used for staging liver fibrosis and steatosis by measuring the velocity of a low frequency (50 Hz) elastic shear wave propagating through the liver.
| Study group | Role | What they receive |
|---|---|---|
| Study group | Patients with metabolic dysfunction-associated fatty liver disease (MAFLD) Receives: Device: Fibroscan | |
| Control group | Healthy control patients Receives: Device: Fibroscan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Level of free triiodothyronine (FT3)
Free triiodothyronine (FT3) will be measured using chemiluminescent immunoassay analysis.
Measured: After the sample is taken (up to 5 minutes)
Secondary outcomes (4)
Level of free thyroxine (FT4)
Free thyroxine (FT4) will be measured using chemiluminescent immunoassay analysis.
Measured: After the sample is taken (up to 5 minutes)
Level of thyroid stimulating hormone
Thyroid stimulating hormone will be measured using chemiluminescent immunoassay analysis.
Measured: After the sample is taken (up to 5 minutes)
Relation between gender and thyroid function
Relation between gender and thyroid function will be assessed.
Measured: After the sample is taken (up to 5 minutes)
Correlation between metabolic data and thyroid function tests
Correlation between metabolic data and thyroid function tests will be assessed.
Measured: After the sample is taken (up to 5 minutes)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2024
- Study start19 Dec 2024
- Primary completion1 May 2025 (estimated)
- Study completion1 May 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thyroid DysfunctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shimaa Abdelmounem Meshaal, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06739330
- Sponsor's protocol ID
- 36264PR929/11/24
- Status last verified
- Dec 2024
- First submitted
- 9 Dec 2024
- Last updated
- 20 Dec 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Thyroid Dysfunction and Its Association With Metabolic Dysfunction-Associated Fatty Liver Disease
- ClinicalTrials.gov ID
- NCT06739330
- Acronym / sponsor ID
- 36264PR929/11/24
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 19 Dec 2024 (actual)
- Primary completion
- 1 May 2025 (estimated)
- Study completion
- 1 May 2025 (estimated)
- First posted
- 18 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to evaluate the prevalence of thyroid dysfunction and its association with metabolic dysfunction-associated fatty liver disease.
Detailed description
One of the most common causes of chronic liver diseases worldwide is metabolic dysfunction-associated fatty liver disease (MAFLD), which affects about 30% of adults. Thyroid hormones are critical in maintaining metabolic homeostasis throughout life and are intimately linked to the liver.
Dysfunctions of the thyroid gland have been implicated as one of the most important risk factors of MAFLD due to its important role in the hepatic synthesis of fatty acid and cholesterol. Maintaining liver metabolism requires thyroid function to be normal, while thyroid disorders may lead to liver disease progression.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study group | – | Device: FibroscanPatients with metabolic dysfunction-associated fatty liver disease (MAFLD) |
| Control group | – | Device: FibroscanHealthy control patients |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- This cross-sectional case-control study will be carried out on 150 patients with metabolic dysfunction-associated fatty liver disease (MAFLD) at Tanta University Hospitals for a period from October 2024 to April 2025 after approval from the Institutional Ethical Committee.
Key inclusion criteria (3 listed)
- Age ≥ 18 years.
- Both sexes.
- Patients with metabolic dysfunction-associated fatty liver disease (MAFLD).
Key exclusion criteria (4 listed)
- History of thyroid disease or treatment (e.g., thyroid nodules, thyroid cancer, hypothyroidism, and hyperthyroidism).
- Patients with alcoholic liver disease take more than 40g of alcohol (or four units) per day.
- Viral hepatitis.
- Pregnant women.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FibroscanFibroscan will be used to assess the stages of fibrosis and steatosis using Dimensional ultrasound TE (transient elastography). Dimensional ultrasound TE (transient elastography) will be used for staging liver fibrosis and steatosis by measuring the velocity of a low frequency (50 Hz) elastic shear wave propagating through the liver. | Device | Control group, Study group |
Primary outcome
Level of free triiodothyronine (FT3)
Time frame: After the sample is taken (up to 5 minutes)
Free triiodothyronine (FT3) will be measured using chemiluminescent immunoassay analysis.
4 secondary outcomes
Level of free thyroxine (FT4)
Time frame: After the sample is taken (up to 5 minutes)
Level of thyroid stimulating hormone
Time frame: After the sample is taken (up to 5 minutes)
Relation between gender and thyroid function
Time frame: After the sample is taken (up to 5 minutes)
Correlation between metabolic data and thyroid function tests
Time frame: After the sample is taken (up to 5 minutes)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Dec 2024.
- Individual participant dataSharing planned: Yes. The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Thyroid Dysfunction and Metabolic Dysfunction-Associated Fatty Liver Disease, run by Tanta University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Shimaa A Meshaal, MD (00966559806580, shaimaa.meshaal2013@med.tanta.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Level of free triiodothyronine (FT3) (time frame: After the sample is taken (up to 5 minutes)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Dec 2024; AzTrials last refreshed its copy on 28 Oct 2026.